Registration Dossier
Registration Dossier
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EC number: 219-741-8 | CAS number: 2517-43-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-methoxybutan-1-ol
- EC Number:
- 219-741-8
- EC Name:
- 3-methoxybutan-1-ol
- Cas Number:
- 2517-43-3
- Molecular formula:
- C5H12O2
- IUPAC Name:
- 3-methoxybutan-1-ol
- Reference substance name:
- methoxybutanol
- IUPAC Name:
- methoxybutanol
- Details on test material:
- - Name of test material (as cited in study report): methoxybutanol
- Physical state: clear, colourless liquid
- Analytical purity: 99.5%
- Lot/batch No.: Hoe CG 0388 0A ZD00 0001
- Expiration date of the lot/batch: August 1996
- pH in water: 7
- Storage condition of test material: in the dark at room temperature in a fume cupbaord
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF Zucht
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.3-3.8 kg
- Fasting period before study: no
- Housing: Individually
- Diet: Altromin 2123 ad libitum and approximately 15 g hay/day
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature: 18±3°C
- Humidity: 55±20%
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light):
IN-LIFE DATES: From: 15-18 October 1991
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 3 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: 2.5 cm x 2.5 cm cellulose patch on a piece of surgical plaster, which was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes; with lukewarm water
- Time after start of exposure: 4 hrs
SCORING SYSTEM: According to OECD guidelines
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 30-60 min
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: Slight erythema (2 on 0-4 scale) present 30-60 mins after end of application. No longer present at the 24 hour reading
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 30-60 min
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: Slight erythema (2 on 0-4 scale) present at 30-60 min after end of treatment
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 30-60 min
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: Very slight erythema (1 on a 0-4 scale) present 30-60 minutes after end of treatment
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No edema observed at any time point
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 30-60 min
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No edema observed at any time point
- Remarks on result:
- other: No edema (0 on 0-4 scale) present at 30-60 min and beyond after end of treatment
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No edema observed at any time point
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 30-60 min
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No edema observed at any time point
- Remarks on result:
- other: No edema (0 on 0-4 scale) present at 30-60 min and beyond after end of treatment
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No edema observed at any time point
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 30-60 min
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No edema observed at any time point
- Remarks on result:
- other: No edema (0 on 0-4 scale) present at 30-60 min and beyond after end of treatment
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No erythema or oedema at 24, 48 or 72 hrs. Methoxybutanol is not a skin irritant.
- Executive summary:
No erythema or oedema at 24, 48 or 72 hrs. Methoxybutanol is not a skin irritant.
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